1. Food Safety and Inspection Service U. S. Department of Agriculture
The Impact of Pathogen Reduction/HACCP on Food Animal Production Systems
Food Safety and Inspection Service
U. S. Department of Agriculture

2. Overview of Presentation
New USDA Pathogen Reduction and HACCP Systems Rule for Plants
In-Plant Residue Control Options
Impact of Rule on Food Animal Production Systems
Importance of HACCP-Compatible Production Practices
Today, I will:
Provide key information on the new USDA’s rule and its regulations that’s important for producers and veterinarians to be aware of;
Describe in-plant residue controls, which consider options for incoming animals;
Provide some insight on how implementation of the rule may impact food animal producers; and
Help you understand why producer Quality Assurance Programs are HACCP-compatible and are important for marketing to plants with HACCP systems,

3. Why Has FSIS Changed Its Inspection Rules?
Focus on Foodborne Illnesses
Salmonella
E. coli O157:H7
Campylobacter
Listeria
As you know, there have been many reports of deaths and illnesses due to these and other foodborne illnesses.
Almost everyday the media is covering news stories about these organisms.
The public’s concerns about the safety of the food supply have been heightened.
Public Health Agencies have raised concerns that more adequate controls form farm to table are needed.

4. Why Has FSIS Changed Its Regulations
First major change in almost 100 years
Need to reduce risks of foodborne illnesses from meat, poultry and egg products
HACCP accepted as science-based preventive risk reduction system
USDA’s Food Safety and Inspection Service recognized it needed to modernize its 90-year-old system.
A critical gap in the inspection program was that it did not adequately prevent or control harmful pathogens on raw meat and poultry.
Changes in FSIS’ total approach to food safety were needed.
HACCP is accepted nationally and internationally as a science-based, preventive risk reduction system.

5. Pathogen Reduction: Hazard Analysis and Critical Control Point (HACCP) Systems Final Rule
Published
July 25, 1996
On July 25, 1996, after much public input, the final rule was published. The rule clarifies that:
Industry’s role is to produce safe meat and poultry products.
FSIS’ role is also to set appropriate food safety standards, to make sure those standards are being met through regulatory oversight, and to take enforcement action when these standards are not met.

6. Pathogen Reduction/HACCP Final Rule
Meat and poultry slaughter and processing establishments must:
Implement Standard Operating Procedures for Sanitation
Test certain products for generic E. coli
Implement HACCP systems
Meet USDA-FSIS Salmonella performance standards
According to the rule:
As of January 27, 1997, plants are required to have SOPs in place to address sanitation
Each plant must describe all procedures it conducts daily, before and during operations
Plants are responsible for detecting, documenting and correcting sanitation deficiencies
Inspectors will continue to look for and require the correction of problems
FSIS will verify SOPs are maintained and effective, and take appropriate action if a plant fails to comply with SOP requirements
Since January 1997, plants have also been required to test carcasses for generic E. coli as an indicator of the adequacy of the plant’s ability to control fecal contamination.
FSIS has adopted performance criteria for E. coli.. FSIS is using the term “criteria” because they are guidelines, not regulatory standards.
The original baseline surveys and performance criteria published in the final rule were based on the excision method of removing meat from carcasses for testing.
FSIS is now conducting new baseline surveys using a nondestructive sponge sampling technique for swine, cattle, and turkeys.
Plants must evaluate their own results using statistical process control.
FSIS will make available interim criteria for use in evaluating sponge samples until final criteria can be set.
Meat and poultry slaughter and processing plants must implement HACCP systems to prevent hazards in meat and poultry products:
Chemical (illegal drug, antibiotic, pesticide and other) residues
Physical hazards (metal, needles, …..)
Microbial pathogens
USDA has set performance standards for Salmonella contamination levels on raw meat and poultry, and plants must meet or be below these levels.

7. Pathogen Reduction/HACCP Final Rule
Slaughter and processing plants must assume more practical responsibility for food safety
The rule makes it clear that:
Slaughter and processing plants are responsible for food safety and must assume more practical responsibility for control of these hazards in their products.

8. Pathogen Reduction/HACCP Final Rule
“Those in control of each segment must bear the responsibility
for identifying and preventing or reducing food safety hazards.”
1996 Rule, Background
The rule also makes it clear that:
Those in control of each segment of the food industry must bear the responsibility for identifying and preventing or reducing food safety hazards.
Although FSIS has regulatory authority primarily in the meat, poultry, and egg processing plants, it has the responsibility to work with all parts of the food production and marketing chain to help ensure we are all doing our best to improve food safety.

9. Farm to Table Food Safety
Animal Production (farm to slaughter)
Slaughter and Processing Plants
Post-Processing Transportation
Wholesale and Retail Stores
Food Service
Consumer Education
FSIS supports efforts at all levels of the Farm to Table Food Safety Chain:
Promotes voluntary adoption of producer quality assurance programs
Is working with FDA to address safe transportation of products
Through the Food Code, works with local and State authorities to improve wholesale, retail and food service food safety practices
Has helped develop the FIGHT BAC! Consumer education campaign. Provides extensive consumer information and Hotline services.

10. Pathogen Reduction/HACCP Final Rule
Foreign Systems must be “equivalent to”
State Systems must be “equal to”
We often are asked “What about imports?”
We are currently working with our trading partners to ensure their systems are equivalent to our HACCP rule.
Our State meat and poultry inspection programs must be “equal to” the federal system.

11. Pre-HACCP Implementation In Plants
On January 27, 1997 plants:
implemented Standard Operating Procedures for Sanitation
began generic E. coli testing for fecal contamination; and
began devising pathogen reduction and HACCP plans
Plants were required, on January 27, 1997, to:
Implement SSOPs
Begin generic E.coli testing for fecal contamination
Begin preparations, including educating themselves, about how they are going to develop PR/HACCP plans. FSIS provided extensive guidance to plants to facilitate implementation.

12. Pathogen Reduction/HACCP Final Rule Implementation
January 26, 1998
Large establishments
January 25, 1999
Small establishments
January 25, 2000
Very small establishments
Plants will need to implement HACCP systems and meet Salmonella performance standards in a phased-in manner according to their size.
Large establishments or more employees
Small establishments - 10 or more but fewer than 500 employees
Very small establishments - Fewer than 10 employees or annual sales of less that $2.5 million.

13. Pathogen Reduction/HACCP Rule and Animal Production
January 26, 1998
75-80% of food animals marketed
January 25, 1999
90-95% of food animals marketed
January 25, 2000
100% of food animals marketed
In terms of percentage of animals whose products end up in interstate or internationally shipped meat and poultry products:
In 1998, about 75-80% of all animals were being marketed to plants implementing HACCP;
This year, when the small plants come on-board, about 90%; and
Starting the year 2000, every animal will be marketed to plants with HACCP systems.

14. Pathogen Reduction/HACCP Rule and Animal Production
There is no regulatory requirement to test live animals for hazards
Rule describes non-regulatory approach for animal production food safety
Part requires plans to evaluate hazards in animals
FSIS does not have, and does not seek regulatory authority over live animals from the farm to the slaughter house gate, and the rule does not have regulatory requirement to test live animals for hazards.
The rule clearly describes our role as promoting voluntary producer efforts to implement food safety preventive practices.
The potential impact on animals marketed to HACCP plants is found in Part This section of the PR/HACCP regulations does require plants to evaluate hazards from live animals.

15. Pathogen Reduction/HACCP Rule Part 417.2(a)
Plants must conduct a hazard
analysis “to determine the food
safety hazards reasonably likely to
occur before, during and after entry
into the establishment”
Part states the plants must conduct a hazard analysis “to determine the food safety hazards reasonably likely to occur before, during and after entry into the establishment.:
The key words for you are “reasonably likely to occur” and “before…entry.”

16. Pathogen Reduction/HACCP Final Rule Part 417.2 Hazards
Physical hazards (foreign objects)
Natural toxins (aflatoxins, etc.)
Zoonotic diseases (bacterial, parasitic)
Other microbial contaminants
Chemical contaminants (pesticides and drug residues)
Food additives and decomposition
The rule also describes what hazards must be considered in a hazard analysis.
All of these, except the last ones, food additives and food decomposition, can apply to incoming animals.

17. Slaughter Plant Residue Control Process
Evaluate significant residue hazards of incoming animals purchased
Develop HACCP plan for residue control
Determine information needed from animal suppliers
Although the focus and the biggest challenge for plants is meeting microbial performance standards, plants are responsible for preventing illegal, or violative, residues from adulterating their meat and poultry products.
Therefore, plants are responsible for residue control:
They must evaluate significant residue hazards of incoming animals;
develop a HACCP plan for controlling residues; and
determine information needed to help develop the residue control plan.

18. Slaughter Plant Residue Control Options for Incoming Animals
Reject animals with a high risk of violative residues
Clearly define purchase criteria
Buy only from suppliers quality assurance certified
When considering how to control residues, plants have many options. They can:
Reject animals with a high risk of violative residues;
develop specifications for high-risk classes of animals for residue violations.
Buy only for suppliers on a QAP. As of January 1999, Hormel will only purchase pigs from producers certified on the Pork quality Assurance Level 3 program.

19. Slaughter Plant Residue Control Options for Incoming Animals
Refuse to purchase from suppliers with past residue violations
Require written assurances or letters of guarantee of no adulteration
Have drug or pesticide use records available
Plants can:
refuse to purchase from suppliers with past residue violations that caused adulteration of meat;
require written assurances or letters of guarantee of no adulteration; or
ask for sufficient history of production practices to determine whether or not significant residue hazards are likely. Plants need to use residue tests appropriate for the treatment history of the animals slaughtered.

20. Slaughter Plant Residue Control Options for Incoming Animals
Periodically test animals or carcasses for residues
Obtain verification of proper drug or pesticide use
Plants can also:
periodically test animals or carcasses for residues; and
To convince suppliers of the importance of preventing violative residues, plants could periodically visit suppliers or obtain independent third party verification that good production practices are being implemented

21. Higher Risk Classes for Violative (Illegal) Drug Residues
Bob veal (3 weeks, 150 lbs.)
Culled cows and bulls
Culled boars and sows
Roaster pigs
Hospital pen clean-outs
There are sufficient historical data that show these classes of animals are more likely to have violative residues than others.
It is imperative proper withdrawal times prior to slaughter are observed.
These are the primary classes of animals on which both plants and FSIS will need to focus residue testing efforts to protect the public’s health.

22. Impact of PR/HACCP Rule on Animal Production Systems
Packers may need more
information on incoming
animals for their HACCP plan.
With the advent of HACCP systems, packers may need more information on incoming animals to develop their HACCP plan and prevent residue adulteration of their products.

23. Impact of PR/HACCP Rule on Animal Production Systems
HACCP-compatible practices provide food safety and market assurances
Quality Assurance Program (QAP) Certification
Animal/premise identification
Producer practices which will provide packers with the information and assurances they need are called “HACCP-compatible.”
They include four key industry standards for good production practices:
1. Being a certified producer on a QAP
2. Identifying treated animals and enabling packers to know the source of animals

24. Impact of PR/HACCP Rule on Animal Production Systems
HACCP-compatible practices (con’d)
Record keeping
Third party verified (audited) processes
HACCP-compatible practices (con’d):
3. Keeping herd health and treatment records, which could supply purchasers with information and improves management, and
4. Another process which may become more important for branded and international markets will be third party verification of food production practices by auditors.

25. Importance of Quality Assurance Certification
Promotes animal health and welfare
Ensures proper drug and antibiotic use
Provides records to assure purchasers of good production practices
By now, I hope you see how important the practices embodied in the QAPS are.
Being a certified producer will not only promote excellence in animal health and welfare, but will also ensure safety of meats by ensuring proper drug and antibiotic use.
Certified producers are more likely to have the proper records which assure purchasers of good production practices.

26. Importance of Quality Assurance Certification
Proven to reduce residue violations
Potentially reduces pathogens through good hygiene and animal health
Improves production efficiency and quality of animals
It has been shown that when producers follow QAPs, they have fewer residue violations, especially repeat violations.
Following the good production practices also potentially reduces contamination with pathogens through good hygiene and animal health.
Quality assurance also increases production efficiency and animal quality.

27. Importance of Verified Quality Assurance Programs
Provides added assurances to purchasers
Provides documentation to support branded products and international markets
National and international marketing systems are moving toward branded products with quality and safety assurances from suppliers along the chain.
Verified programs that have been audited by a third party, such as an accredited veterinarian or other trained expert, may provide added value to purchasers because of the additional assurances and documentation of certain practices being followed.

28. Milk and Dairy Beef Quality Assurance Program
Food Safety Control Points
Valid veterinary/client/patient relationship for drug use and health
Storing and administering drugs
Milk drug screening tests
The Dairy QAP has taken a HACCP-like approach to looking at specific food safety control points for residue avoidance.
Ten control points are clearly described.
Although the QAP focuses on residue avoidance in mil,, critical control points for preventing residues in beef are stressed.
Producers who follow the practices in the Milk and Dairy Beef QAP will be able to provide slaughter plants the assurances needed for their residue control plans for culled cows and bob veal calves.

29. Milk and Dairy Beef Quality Assurance Program
Certification by veterinarians is an educational process
Although the Milk & Dairy QAP certification is primarily an educational process for residue food safety and milk quality, the practices of record-keeping, animal identification, maintaining good herd health and hygiene, educating all on handling drugs properly, and working with a veterinarian are keys to success when marketing culled cows and bob veal calves to slaughter plants implementing HACCP systems.
Plants will have more trust when buying culled cows and bob veal calves.from producers with QA programs.
Recently, this Program has also incorporated Best management Practices for Biosecurity to control infectious diseases and hopefully reduce risk of foodborne pathogens by good sanitation and herd health management.

30. Pork Quality Assurance Certification Program
Level I
Food safety and HACCP awareness
FDA animal drug use compliance policy guide explained
Current regulatory systems included
Level II: Educational self test

31. Pork Quality Assurance Certification Program
Level III: Veterinarian Assisted
10 Good Production Practices Defined
1 to 6: Residue avoidance practices
7 to 9: Animal health, care and feeding
10: Complete checklist annually
Recertify every two years
The Level 3 PQA contains industry standards for good production practices.
It requires producers to go to educational meeting and recertify every two years with a veterinarian or swine expert.
According to a recent article in the National Hog Farmer, up to now, pork packers have borne the brunt of the responsibility for food safety. Starting in January 1999, Hormel will buy only from producers certified on the Level 3 QAP.
This will provide them with added assurances that producers are educated about industry standards.

32. Beef Quality Assurance Certification Program
Guidelines for proper animal health product use
Awareness of feed ingredients and potential residues
Total Quality Manage- ment education
Tailored State by State
The Beef QAP is often tailored by States.
In the Northeast, there has been a focus on culled dairy cattle and how best to work with dairy producers to avoid violative residues in beef.
The BQA stresses total quality management practices for improved beef quality and residue safety

33. Animal Production and Pathogen Reduction
Research needed to determine food safety control points from farm to slaughter
What practices will reduce pathogens in live animals and result in reducing contamination on carcasses?
We’ve talked a lot about residue avoidance, but what about foodborne pathogens?
Although plants will be testing for generic E. coli and some will be checking for pathogens, there are no requirements to test live animals or to traceback to the farm. Some integrated poultry plants are working closely with their suppliers on ways to practically reduce contamination of birds with Salmonella and Campylobacter.
Research is needed to know what will reliably reduce pathogens in live animals and carcasses.

34. Animal Production and Pathogen Reduction
Research needed for food safety control points from farm to slaughter (con’d)
Can animals be sorted pre-slaughter to reduce contamination on carcasses?
Plants may also be interested in knowing if animals someday can be sorted based on their risk of carrying pathogens.
Plants could process high-risk animals at the end of the day or make other decisions based on food safety.
Much research is needed to determine if sorting of animals pre-slaughter could consistently reduce contamination of carcasses.

35. Salmonella in National Culled Dairy Cattle Survey 1996-1997
FSIS/University collaborative project
5,000 cecal-colon samples at slaughter
Winter and summer seasons
Good and poor conditioned cows had no significant difference in Salmonella shedding
To look at the possibility of sorting culled dairy cattle prior to slaughter, FSIS and the Food Animal Production Medicine Consortium conducted a pilot survey of over 5,000 cows at slaughter across the country during both winter and summer seasons.
The hypothesis was that cows in poor body condition would shed Salmonella more than cows in good body condition.
We could not prove this.
The shedding of Salmonella at slaughter is much more complex that body condition. Another survey is on-going looking at livestock markets and transportation distances.

36. Summary of Presentation
New USDA Pathogen Reduction and HACCP Systems for Plants
In-Plant Residue Control Options
Impact of Role on Food Animal Production Systems
Importance of HACCP-Compatible Production Practices
In summary, I have discussed:
the new PR/HACCP Systems rule for meat and poultry plants and the farm-to-table concepts for food safety;
the options plants have for addressing residue control and incoming animals;
the potential effect this rule may have on food animal producers; and
the importance of being on Quality Assurance Programs. These programs all are HACCP-compatible; in other words, they are the types of practices plants need for reducing risks of chemical, physical and microbial hazards in the animals they purchase.

37. Summary
New Pathogen Reduction/HACCP Systems Rule implemented in plants requires physical, chemical and microbial hazard controls
Food animal producers are being affected
Producers are being affected because the new rule covers physical, chemical and microbial hazard control in meat and poultry slaughter plants.
An example is that Hormel and most large pork packers now require suppliers to be on the Pork Level 3 QAP and have their certification card.
However, plants have many options on how to address these hazards when considering the live animals supplied to them.

38. Summary Packers may need more information on animals supplied
Quality Assurance Program Certification
Animal/premise supplier identification
Treatment and disease records
Packers may need more information on the animal supplied.
The information can best be supplied by producers who:
are on QAPs and are certified;
have animal or premise identification systems place; and
keep good treatment and disease records which improves productivity, herd health, and helps prevent food safety problems.

39. Good Management Productivity (Value) Animal Health
Food Safety
Productivity
(Value)
Animal Health
Good Management
Quality Assurance Program
Animal Identification
Production Treatment Records
Proper Drug Use
Feed Quality & Safety
Culling Practices
General Sanitation
Waste Management
Good Management Practices provide a solid basis for producing food animals which are safe, wholesome and profitable. The foundation of good management encompasses animal health, food safety and sustainable productivity.

40. Summary
Food animal producers who follow good production practices and are Quality Assurance Program Certified will be able to meet food safety demands in the HACCP era.
As we address consumer concerns about food safety, meet the demands of the HACCP era, and seek international markets, those producers who follow industry standards for good production practices, and who are certified on a QAP, will best be able to turn these challenges into opportunities.
Working together, we will build consumer confidence in the safety of our food supply from farm to table.